Cleared Traditional

K803110 - PROTEOLYTIC ENZYME CONTROL
(FDA 510(k) Clearance)

K803110 · American Dade · Chemistry device

Feb 1981

Decision

69d

Days

Class 2

Risk

K803110 is an FDA 510(k) clearance for the PROTEOLYTIC ENZYME CONTROL. This device is classified as a Assay, Alpha-2-antiplasmin (Class II - Special Controls, product code LGP).

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on February 17, 1981, 69 days after receiving the submission on December 10, 1980.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number	K803110 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 10, 1980
Decision Date	February 17, 1981
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—